このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

2019年1月22日 更新者:MC10 Inc.

A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.

Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.

調査の概要

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ohio
      • Cincinnati、Ohio、アメリカ、45212
        • CTI Clinical Research Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~99年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Male or female volunteers, at least 18 years of age at the time of screening visit;
  2. Fluent in English;
  3. The subject is willing to comply with the protocol specified evaluations;
  4. Subject is willing and cognitively able to sign informed consent

Exclusion Criteria:

  1. Pregnancy;
  2. Positive urine drug screen
  3. History of active (clinically significant) skin disorders;
  4. History of allergic response to silicones or adhesives;
  5. Subjects with electronic implants of any kind (e.g. pacemaker)
  6. History of sleep disorders or self-reported insomnia or other sleep conditions;
  7. Broken, damaged or irritated skin or rashes near the sensor application sites;
  8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
  9. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:Single Arm

This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.

This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.

Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
FDA cleared reference device that monitors respiration rate in subjects
Visual annotation of subject posture and other activities used for reference

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
時間枠:2 days after informed consent
Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
時間枠:2 days after informed consent
Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
時間枠:2 days after informed consent
HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
時間枠:2 days after informed consent
Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Activity Classification as Compared to Visual Annotation
時間枠:2 days after informed consent
The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.
2 days after informed consent
Accuracy of Step Count Compared to an Observer's Manual Count
時間枠:2 days after informed consent
The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.
2 days after informed consent
Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
時間枠:2 days after informed consent
Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.
2 days after informed consent
Accuracy of Posture Classification as Compared to Visual Annotation
時間枠:2 days after informed consent
The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.
2 days after informed consent
Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
時間枠:2 days after informed consent
The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented.
2 days after informed consent

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年7月31日

一次修了 (実際)

2017年8月25日

研究の完了 (実際)

2017年8月30日

試験登録日

最初に提出

2017年8月16日

QC基準を満たした最初の提出物

2017年8月17日

最初の投稿 (実際)

2017年8月22日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月25日

QC基準を満たした最後の更新が送信されました

2019年1月22日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • MC10-PTL-103

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Physiological signal monitorの臨床試験

3
購読する